Surgical Outcomes and Quality Improvement Center (SOQIC), Department of Surgery and Center for Healthcare Studies, Feinberg School of Medicine, Northwestern University, Chicago, Illinois.
Department of Quality Strategies, Northwestern Memorial Hospital, Chicago, Illinois.
JAMA. 2020 Nov 24;324(20):2058-2068. doi: 10.1001/jama.2020.21115.
Certificate of need laws provide state-level regulation of health system expenditure. These laws are intended to limit spending and control hospital expansion in order to prevent excess capacity and improve quality of care. Several states have recently introduced legislation to modify or repeal these regulations, as encouraged by executive order 13813, issued in October 2017 by the Trump administration.
To evaluate the difference in markers of hospital activity and quality by state certificate of need status. These markers include hospital procedural volume, hospital market share, county-level procedures per 10 000 persons, and patient-level postoperative outcomes.
DESIGN, SETTING, AND PARTICIPANTS: A cross-sectional study involving Medicare beneficiaries aged 65 years or older who underwent 1 of the following 10 procedures from January 1, 2016, through November 30, 2018: total knee or hip arthroplasty, coronary artery bypass grafting, colectomy, ventral hernia repair, lower extremity vascular bypass, lung resection, pancreatic resection, cystectomy, or esophagectomy.
State certificate of need regulation status as determined by data from the National Conference of State Legislatures.
Outcomes of interest included hospital procedural volume; hospital market share (range, 0-1; reflecting 0%-100% of market share); county-level procedures per 10 000 persons; and patient-level postoperative 30-day mortality, surgical site infection, and readmission.
A total of 1 545 952 patients (58.0% women; median age 72 years; interquartile range, 68-77 years) at 3631 hospitals underwent 1 of the 10 operations. Of these patients, 468 236 (30.3%) underwent procedures in the 15 states without certificate of need regulations and 1 077 716 (69.7%) in the 35 states with certificate of need regulations. The total number of procedures ranged between 729 855 total knee arthroplasties (47.21%) and 4558 esophagectomies (0.29%). When comparing states without vs with certificate of need regulations, there were no significant differences in overall hospital procedural volume (median hospital procedure volume, 241 vs 272 operations per hospital for 3 years; absolute difference, 31; 95% CI, -27.64 to 89.64; P = .30). There were no statistically significant differences between states without vs with certificate of need regulations for median hospital market share (median, 28% vs 52%; absolute difference, 24%; 95% CI, -5% to 55%; P = .11); procedure rates per 10 000 Medicare-eligible population (median, 239.23 vs 205.41 operations per Medicare-eligible population in 3 years; absolute difference, 33.82; 95% CI, -84.08 to 16.43; P = .19); or 30-day mortality (1.17% vs 1.33%, odds ratio [OR], 1.04; 95% CI, 0.93 to 1.16; P = .52), surgical site infection (1.24% vs 1.25%; OR, 0.93; 95% CI, 0.83 to 1.04; P = .21), or readmission rate (9.69% vs 8.40%; OR, 0.80; 95% CI, 0.57 to 1.12; P = .19).
Among Medicare beneficiaries who underwent a range of surgical procedures from 2016 through 2018, there were no significant differences in markers of hospital volume or quality between states without vs with certificate of need laws. Policy makers should consider reevaluating whether the current approach to certificate of need regulation is achieving the intended objectives and whether those objectives should be updated.
证书的需要法律提供国家一级的卫生系统支出的监管。这些法律旨在限制支出和控制医院扩张，以防止过度的能力和提高医疗质量。一些州已经最近引入立法来修改或废除这些法规，鼓励特朗普政府于 2017 年 10 月发布的行政命令 13813。
评估的状态证书的需要由国家地位的医院活动和质量的差异。这些标志物包括医院手术量，医院市场份额，县一级的程序每 10000 人，和病人水平术后结果。
设计、设置和参与者：一项横断面研究，涉及 Medicare 受益人年龄 65 岁或以上谁进行了 10 以下的程序从 2016 年 1 月 1 日，通过 2018 年 11 月 30 日：全膝关节或髋关节置换术，冠状动脉旁路移植术，结肠切除术，腹疝修补术，下肢血管旁路，肺切除术，胰腺切除术，膀胱切除术，或 esophagectomy。
国家证书的需要监管地位，由来自国家立法会议的数据确定。
感兴趣的结果包括医院手术量;医院市场份额(范围，0-1;反映 0%-100%的市场份额);县一级的程序每 10000 人;和病人水平术后 30 天死亡率，手术部位感染，和再入院率。
共有 1545952 例患者(58.0%女性;中位数年龄 72 岁;四分位间距，68-77 岁)在 3631 家医院进行了 10 项手术中的 1 项。这些患者中，468236(30.3%)在没有证书的需要法规的 15 个州进行了手术，1077716(69.7%)在有证书的需要法规的 35 个州进行了手术。手术的总数在 729855 例全膝关节置换术(47.21%)和 4558 例食管切除术(0.29%)之间。在比较没有与证书的需要法规的州时，在医院总手术量方面没有显著差异(中位数医院手术量，241 例与 272 例手术/医院 3 年;绝对差异，31;95%置信区间，-27.64 到 89.64;P=0.30)。在没有与证书的需要法规的州之间，在中位数医院市场份额方面没有统计学上的显著差异(中位数，28%对 52%;绝对差异，24%;95%置信区间，-5%到 55%;P=0.11);每 10000 名 Medicare 合格人口的程序率(中位数，239.23 对 3 年每 10000 名 Medicare 合格人口 205.41 例手术;绝对差异，33.82;95%置信区间，-84.08 到 16.43;P=0.19);或 30 天死亡率(1.17%对 1.33%，优势比[OR]，1.04;95%置信区间，0.93 到 1.16;P=0.52)，手术部位感染(1.24%对 1.25%;OR，0.93;95%置信区间，0.83 到 1.04;P=0.21)，或再入院率(9.69%对 8.40%;OR，0.80;95%置信区间，0.57 到 1.12;P=0.19)。
在 Medicare 受益人谁进行了一系列的手术从 2016 年到 2018 年，在没有与证书的需要法律的州之间没有显著差异的医院容量或质量的标志物。政策制定者应该考虑重新评估当前的证书的需要监管方法是否达到预期目标，以及这些目标是否应该更新。
